SeaSpine Cambria System

SeaSpine Cambria System is an FDA 510(k)-cleared medical device (K171046) manufactured by SeaSpine Orthopedics Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 6, 2017. Regulation: 8.